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The American Society of Breast Surgeons.
Annals of Surgical Oncology

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Prospective Evaluation of Residual Breast Tissue After Skin- or Nipple-Sparing Mastectomy: Results of the SKINI-Trial

Bärbel Papassotiropoulos MD, Uwe Güth MD, Federica Chiesa MD, Christoph Rageth MD, Esther Amann MD, Astrid Baege MD, Constanze Elfgen MD, Zsuzsanna Varga MD, Linda Moskovszky MD, Katharina Endhardt MD, Regina Masser MD, Marianne Tinguely MD, Jian Farhadi MD, Alessia Lardi MD, Florian Dammann MD, Joachim Diebold MD, Qiyu Li MSc, Peter Dubsky MD, Christoph Tausch MD
Breast Oncology
Volume 26, Issue 5 / May , 2019

Objective

This study was designed to investigate the presence of residual breast tissue (RBT) after skin-sparing mastectomy (SSM) and nipple-sparing mastectomy (NSM) and to analyse patient- and therapy-related factors associated with RBT. Skin-sparing mastectomy and NSM are increasingly used surgical procedures. Prospective data on the completeness of breast tissue resection is lacking. However, such data are crucial for assessing oncologic safety of risk-reducing and curative mastectomies.

Methods

Between April 2016 and August 2017, 99 SSM and 61 NSM were performed according to the SKINI-trial protocol, under either curative (n = 109) or risk-reducing (n = 51) indication. After breast removal, biopsies from the skin envelope (10 biopsies per SSM, 14 biopsies per NSM) were taken in predefined radial localizations and assessed histologically for the presence of RBT and of residual disease.

Results

Residual breast tissue was detected in 82 (51.3%) mastectomies. The median RBT percentage per breast was 7.1%. Of all factors considered, only type of surgery (40.4% for SSM vs. 68.9% for NSM; P < 0.001) and surgeon (P < 0.001) were significantly associated with RBT. None of the remaining factors, e.g., skin flap necrosis, was associated significantly with RBT. Residual disease was detected in three biopsies.

Conclusions

Residual breast tissue is commonly observed after SSM and NSM. In contrast, invasive or in situ carcinomas are rarely found in the skin envelope. Radicality of mastectomy in this trial is not associated with increased incidence of skin flap necrosis.

ClinicalTrials.gov Identifier NCT03470909.

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